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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-18
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2019
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported event will not be returned for evaluation as it was discarded; therefore, the event cause could not be determined. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that there was movement during placement of a medtronic flow diverter. The flow diverter dropped proximal to the aneurysm and had to be taken out. It had missed the landing zone even though it was placed at least 3mm past the aneurysm neck on each side. A new flow diverter was implanted to complete the procedure successfully. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 6mm x 4mm located in the right p-comm. The distal and proximal landing zone was 3. 7mm x 4. 4mm. The patient¿s vasculature was moderate in tortuosity. The patient was not on dual antiplatelet therapy.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8774497
MDR Text Key150530237
Report Number2029214-2019-00706
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2021
Device Model NumberPED-450-18
Device Lot NumberA690240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/10/2019 Patient Sequence Number: 1
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